Publisher : International Journal of Pharmacy and Pharmaceutical Sciences
Campus : Kochi
School : School of Medicine
Department : Medical Oncology
Year : 2014
Abstract : Objective: To assess the clinical profile of patients receiving Decitabine for myelodysplastic syndromes (MDS) and Acute myeloid leukemia (AML).Methods: 14 patients had been initiated on Decitabine which included 11 MDS patients and 3 AML patients. Response was defined for MDS according to the International Working Group (IWG) 2006 criteria, whereas for AML according to IWG-AML 2003 criteria. Toxicities were graded according to the National Cancer Institute/Common Toxicity Criteria guidelines, version four.Results: Out of the 14 patients overall response was achieved in 7 patients (50%) including 4 complete remission (29%), 1 partial remission (7%) and 2 stable diseases with hematological improvement (HI-N 1, HI-P 1 (14%). In case of MDS over all response was found in 6 patients (55%) including 3 patients with CR (27.5%), 1 PR (9%) and 2 stable diseases with HI (27%). Out of 14 patients 5 patients showed treatment failure (36%). One MDS patient showed disease progression and other one discontinued Decitabine. The most commonly occurred adverse effect noted was neutropenia which was observed in 13 patients (92.85%) and least commonly occurred were fatigue (13%) and fever (13%).Conclusion Almost similar efficacy and safety profile were observed after comparing our data with ADOPT trial conducted by David P Steensma et al. The patients with MDS and AML had a lower median age at presentation compared with western data. We also noticed a worsening of pre-existing renal dysfunction observed in one patient after the second cycle of Decitabine which reversed upon stopping the drug.